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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02169141 |
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Date of registration:
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12/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients
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Scientific title:
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Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02169141 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Belarus
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Contacts
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Name:
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JW C Alffenaar, PhD PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UMCG |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age> 18yrs
- culture positive
- diagnosis of MDR-TB
Exclusion Criteria:
- DM2
- Pregnancy
- allergy to IV canula material
- insertion of IV canula not possibele
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
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Intervention(s)
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Other: Pharmacokinetics
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Primary Outcome(s)
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Cmax/MIC ratio of Capreomycin
[Time Frame: after day 8 of treatment]
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AUC/MIC ratio of Levofloxacin
[Time Frame: after day 8 of treatment]
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Secondary Outcome(s)
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Clearance
[Time Frame: after day 8 of treatment]
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Volume of Distribution
[Time Frame: after day 8 of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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